MediciNova Announces MN-166 (ibudilast) Opioid Withdrawal and Analgesia Data Presentation at the American Academy of Neurology

MediciNova Announces MN-166 (ibudilast) Opioid Withdrawal and Analgesia Data
Presentation at the American Academy of Neurology Annual Meeting
SAN DIEGO, March 20, 2013 (GLOBE NEWSWIRE) -- MediciNova, Inc., a
biopharmaceutical company that is publicly traded on the NASDAQ Global Market
(Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code
Number: 4875), today announced that data from a Phase 1b/2a study of MN-166
(ibudilast) in opioid withdrawal and analgesia will be presented during a
poster session from 5:30p.m. to 7:00p.m. at the American Academy of Neurology
(AAN) Annual Meeting in San Diego on March 21, 2013.
"MN-166 is an intriguing compound that has the potential to help opioid and
heroin addicts cease their opioid use with reduced withdrawal symptoms," said
Sandra Comer, Ph.D., Professor of Clinical Neurobiology in the Department of
Psychiatry at the College of Physicians and Surgeons of Columbia University,
Research Scientist at the New York State Psychiatric Institute and principal
investigator of the study. "The preliminary safety and efficacy data generated
by this clinical trial provided the necessary information to launch the
NIDA-funded Phase 2a clinical trial of MN-166 in prescription opioid or heroin
abusers that is currently underway. We are excited to be a part of this
critical research that may provide new options for these patients."
Dr. Comer will present "A Drug Candidate for Improving Opioid Analgesia and
Attenuating Dependence and Tolerance: An Exploratory Trial of Ibudilast in
Morphine Withdrawal and Analgesia in Heroin Addicts" on March 21 at the AAN.
Preliminary data analyses from this study were presented in 2011 at the
College on Problems of Drug Dependence meeting and the current presentation
includes final data analyses.
According to the Substance Abuse and Mental Health Services Administration's
(SAMHSA) 2011 National Survey on Drug Use and Health, there are approximately
1.4 million people with nonmedical pain reliever dependence and approximately
369,000 people with heroin dependence in the U.S. The economic costs of
nonmedical use of prescription opioids in the U.S. was estimated at $53.4
billion in 2006, according to a study published in The Clinical Journal of
Pain (Hansen RN et al., 2011 Mar-Apr; 27(3):194-202). Most of the medications
currently approved by the FDA for the treatment of opioid dependence are
opioid agonists that carry the risk of secondary dependence or abuse and have
opioid-related safety risks.
In this clinical study, heroin addicts were randomized into separate treatment
groups of placebo, 40 mg/day MN-166 or 80 mg/day MN-166. Safety and
tolerability and preliminary efficacy were major analyzed outcomes.
Dose-related ibudilast efficacy was also observed in the study. For example,
physical withdrawal symptoms were significantly reduced (p≤0.05) by MN-166
treatment as measured by the Subjective Opioid Withdrawal Scale (SOWS) and
oxycodone-mediated analgesia (McGill pain questionnaire) was significantly
enhanced (p≤0.05) by 80 mg/day ibudilast compared to placebo.Moreover,
opioid-related pupil constriction was greater in the 80 mg/day ibudilast group
compared to the placebo group (p≤0.05) suggesting lessened tolerance
development. Ibudilast was safe and well-tolerated in the study with no
serious adverse events, no discontinuations due to treatment and no impact on
opioid respiratory changes compared to placebo.
"We are pleased with the outcome of this study and excited that it was
selected for presentation at AAN," commented Dr. Yuichi Iwaki, President and
CEO of MediciNova. "We look forward to the next milestone in this indication
which will be completion of the ongoing Phase 2a clinical trial of MN-166 in
subjects addicted to prescription opioids or heroin."
About the Study
The trial was led by Sandra Comer, Ph.D., Professor of Clinical Neurobiology,
and additional drug addiction researchers, including Ziva Cooper, Ph.D.,
Assistant Professor of Clinical Neurobiology at Columbia. The 21-day,
inpatient, double-blind, placebo-controlled study enrolled 30
non-treatment-seeking, heroin-dependent volunteers who were maintained on oral
morphine for the first 14 days. In the first week, all subjects received
placebo and on day 8, participants were randomized to continue placebo (P),
low dose (L; 20 mg twice daily (40 mg/day)) ibudilast, or high dose (H; 40 mg
twice daily (80 mg/day)) ibudilast. Data were analyzed from 10 subjects
completing each treatment arm. In the third week, morphine was no longer
administered so that withdrawal phenomena during detoxification could be
monitored.
Primary endpoints were safety/tolerability and changes in total subjective
opioid withdrawal scale (SOWS) score. Secondary endpoints included other
withdrawal scales and analgesia and physiological measurements. Indicators of
altered analgesia or tolerance (reduced opioid effects with repeat morphine
exposure) were assessed in laboratory sessions with oxycodone administration
and cold water immersion of the hand followed by objective and subjective pain
endpoints.
About MN-166 Clinical Development in Addiction
Clinical development of MN-166 is ongoing in both methamphetamine addiction
and opioid addiction. These clinical trials are conducted by some of the
country's leading experts in opioid and methamphetamine addiction. A Phase 1b
clinical trial of MN-166 in methamphetamine dependence is near completion at
UCLA. A Phase 2 outpatient clinical trial of MN-166 in methamphetamine
dependence, led by investigators at UCLA, has been funded by NIDA. In opioid
addiction, a second NIDA-funded clinical trial of MN-166 in prescription
opioid or heroin abusers is currently ongoing with the investigators at
Columbia University and the New York State Psychiatric Institute. This ongoing
Phase 2a trial involves in-unit treatment for six weeks with either placebo or
100 mg/day MN-166 and is tailored to confirm some prior endpoints and to
assess the effect of MN-166 on opioid craving and self-administration
behavior.
About MN-166 (ibudilast)
MN-166 has been marketed in Japan and Korea since 1989 to treat
cerebrovascular disorders, including post-stroke complications, and bronchial
asthma. MediciNova licensed MN-166 (ibudilast), from Kyorin Pharmaceutical in
October 2004 for potential utility in relapsing remitting multiple sclerosis.
MediciNova scientists and collaborators independently established evidence of
ibudilast utility in opioid and methamphetamine addiction as well as chronic
neuropathic pain.
MN-166 is a first-in-class, orally bioavailable, small molecule
phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration
inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines
including IL-1ß, TNF-a, and IL-6, and may upregulate the anti-inflammatory
cytokine IL-10 and neurotrophic factors. It attenuates the activation of brain
glial cells in neurological disorders and that cellular action is thought to
contribute to its therapeutic action. Accordingly, MediciNova's development
efforts in progressive MS and chronic neuropathic pain are founded upon both
anti-neuroinflammatory and neuroprotective actions which have been
demonstrated in preclinical and clinical data.
MediciNova's method-of-use patent for MN-166 for the treatment of addiction
expires no earlier than 2030 in the U.S. In the approved and pending
grant-funded MN-166 trials, one of MediciNova's commitments is to provide
delayed-release ibudilast final product. A drug supply collaboration with
Taisho Pharmaceutical Industries, Ltd., owned by Teva Pharmaceuticals, has
expanded to include development of higher dosage strength ibudilast capsules.
About MediciNova
MediciNova, Inc. is a publicly traded biopharmaceutical company founded upon
acquiring and developing novel, small-molecule therapeutics for the treatment
of diseases with unmet need with a commercial focus on the U.S. market.
MediciNova's current strategy is to focus on its two prioritized product
candidates, MN-166 (ibudilast) for neurological disorders, and MN-221 for the
treatment of acute exacerbations of asthma. MN-166 is being developed in Phase
1 and Phase 2 clinical trials for drug dependence and pain, largely through
investigator sponsored trials and outside funding. Proceeding with
proof-of-concept Phase 2b trial(s) in Progressive MS is dependent on receipt
of funding, which we are pursuing. MediciNova is engaged in strategic
partnering and consortium funding discussions to support further development
of both the MN-221 and ibudilast/MN-166 programs. For more information on
MediciNova, Inc., please visit www.medicinova.com.
The MediciNova, Inc. logo is available at
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Statements in this press release that are not historical in nature constitute
forward-looking statements within the meaning of the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. These forward-looking
statements include, without limitation, statements regarding our clinical
development strategies, including future development, statements regarding the
progress of clinical trials, statements regarding expectations for the
ibudilast/MN-166 program, including development of ibudilast/MN-166 for
certain indications and expectations on future progress in the development of
our drug candidates, expected timing of clinical trial results and any
implication as to the results of our development, partnering and funding
efforts, the implication of patent terms and potential product exclusivity and
the implication that the company will have the ability to execute on its
priorities. These forward-looking statements may be preceded by, followed by
or otherwise include the words "believes," "expects," "anticipates,"
"intends," "estimates," "projects," "can," "could," "may," "will," "would," or
similar expressions. These forward-looking statements involve a number of
risks and uncertainties that may cause actual results or events to differ
materially from those expressed or implied by such forward-looking statements.
Factors that may cause actual results or events to differ materially from
those expressed or implied by these forward-looking statements, include, but
are not limited to, risks of obtaining future partner or grant funding for
development of MN-221 and MN-166 and risks of raising sufficient capital when
needed to fund MediciNova's operations and contribution to clinical
development, risks and uncertainties inherent in clinical trials, including
the potential cost, expected timing and risks associated with clinical trials
designed to meet FDA guidance and the viability of further development
considering these factors, product development and commercialization risks,
the uncertainty of whether the results of clinical trials will be predictive
of results in later stages of product development, the risk of delays or
failure to obtain or maintain regulatory approval, risks associated with the
reliance on third parties to sponsor and fund clinical trials, risks regarding
intellectual property rights in product candidates and the ability to defend
and enforce such intellectual property rights, the risk of failure of the
third parties upon whom MediciNova relies to conduct its clinical trials and
manufacture its product candidates to perform as expected, the risk of
increased cost and delays due to delays in the commencement, enrollment,
completion or analysis of clinical trials or significant issues regarding the
adequacy of clinical trial designs or the execution of clinical trials, and
the timing of expected filings with the regulatory authorities, MediciNova's
collaborations with third parties, the availability of funds to complete
product development plans and MediciNova's ability to obtained third party
funding for programs and raise sufficient capital when needed, and the other
risks and uncertainties described in MediciNova's filings with the Securities
and Exchange Commission, including its annual report on Form 10-K for the year
ended December 31, 2011 and its subsequent periodic reports on Forms 10-Q and
8-K. Undue reliance should not be placed on these forward-looking statements,
which speak only as of the date hereof. MediciNova disclaims any intent or
obligation to revise or update these forward-looking statements.
CONTACT: INVESTOR CONTACT:
Mike Coffee
Chief Business Officer
MediciNova, Inc.
(858) 736-7180
coffee@medicinova.com
MEDIA CONTACT:
Stephanie Ashe
Continuum Health Communications
(650) 245-0425
sashe@continuumhealthcom.com
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